CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
plain crystalline niacin, exercise, saunadrug
Likely dose
plain crystalline niacin, exercise, sauna 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01672710
NCT01672710Phase 2Completed

Pilot Study of Application of the Hubbard Detoxification Program to Veterans With Gulf War Illness

University at Albany·interventional·Posted Aug 27, 2012·Updated Apr 13, 2020

In Brief

A Phase 2 clinical trial evaluating plain crystalline niacin, exercise, sauna for Gulf War Illness. Completed, enrolled 32 participants across 1 site.

Detailed Summary

Gulf War illness is found in about one fourth of veterans of the 1990-1991 Gulf War and is characterized by persistent memory and concentration problems, headaches, fatigue and muscle and joint pain. It is not known what causes the illness, but exposure to chemicals is suspected. The Hubbard detoxification program consists of exercise and sauna therapy together with administration of several dietary supplements, particularly crystalline niacin used at increasing concentrations over a period of about four weeks. The investigators hypothesize that this program will reduce symptoms, as tested by administration of cognitive and quality of life tests and serum clinical chemistry tests.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 27, 2012
Enrollment StartApr 1, 2010
Primary CompletionAug 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 13.8 years ago

Interventions

plain crystalline niacin, exercise, saunadrug

A four to six week regimen consisting of daily, supervised, mild-moderate exercise as tolerated for 20 minutes, supervised, intermittent Finnish saunas (at about 140'F) sauna time with breaks and showers, gradually increased as tolerated to approximately 4 hours, dietary supplements including immediate release niacin in gradually increasing doses from 100 mg to a maximum of 5000 mg per day, salt and water, other vitamins, minerals and oils per Hubbard protocol.